RuiShun Bio Accelerates Development of CD19-CAR-DNT Therapy and Expands into Autoimmune Diseases

ZhongshanNovember 2, 2023PR Newswire -- Recently, the new drug registration clinical research application for RJMty19 injection, an immunocyte product under development by Zhejiang Ruishun Biotech Co., Ltd. (hereinafter referred to as "Ruishun Biotech") for the treatment of relapsed/refractory autoimmune diseases (r/r AID), has been officially accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) (Acceptance No.: CXSL2300661). The main active ingredient of RJMty19 injection is CD19-CAR-DNT cells.

DNT cells are a subset of T cells naturally present in human peripheral blood, and are called double-negative T cells (DNT) because they do not express CD4 and CD8 molecules.

According to Dr. Liming Yang, Chairman and Chief Scientific Officer of Zhejiang Ruishun Biotech Co., Ltd.,DNT cells have potent anti-acute myeloid leukemia (AML) cell activity and advantages such as strong tumoricidal activity and robust in vitro expansion capability.

November 2020RC1012 Injection (allogeneic DNT cells extracted from peripheral blood of healthy individuals and expanded in vitro) has been approved by the CDE to conduct a Phase I clinical trial for the treatment of relapsed/refractory acute myeloid leukemia. It is the first allogeneic T-cell product in China to enter a new drug registration clinical trial, with plans to complete patient enrollment for the Phase I clinical trial this year.

January 2023RC1012 Injection for the Prevention of Relapse after Allogeneic Hematopoietic Stem Cell Transplantation in Acute Myeloid Leukemia Granted CDE Approval for Phase Ⅰ/Ⅱ Clinical Trials; Patient Enrollment for Phase Ⅰ to Be Completed This Year, with Phase Ⅱ Enrollment to Begin.

On October 24, 2023, the new drug registration clinical research application for RJMty19 Injection for the treatment of relapsed/refractory B-cell non-Hodgkin lymphoma (r/r NHL) was officially accepted by the CDE. RJMty19 Injection is the second-generation DNT cell therapy developed by Zhejiang Ruishun Biotech Co., Ltd. based on DNT technology, with its main active component being CD19-CAR-DNT cells. It is an innovative, globally-patented, off-the-shelf universal CAR-DNT cell therapy product developed by Zhejiang Ruishun Biotech Co., Ltd. using a humanized CD19-CAR domain.

Currently, nine autologous CAR-T cell products have been approved globally for the treatment of hematologic tumors, including three autologous CAR-T cell products approved in China.Dr. Yang Liming pointed out that autologousCAR-T cell products must be manufactured on a one-to-one basis, meaning one CAR-T cell product for each patient, so they cannot be generalized. This results in the current high cost of CAR-T cell therapy, which can exceed one million Chinese yuan. As a result, many blood cancer patients in China are unable to afford it, losing the opportunity for a new lease on life.。

"Only through universal application can treatment processes be simplified, thereby reducing"The price of CAR-T therapy, while DNT/CAR-DNT therapy has a natural advantage in this aspect," said Dr. Yang Liming.，"A large amount of clinical research data has proven that allogeneic DNT cell therapy does not cause graft-versus-host disease or other severe toxic side effects. Therefore, DNT cells extracted from healthy donor peripheral blood and expanded in vitro can be used for all patients, demonstrating universality."

Autoimmune diseases (shortened as "self-immune diseases") refer to diseases caused by immune responses to self-antigens, leading to damage of one's own tissues. The prevalence rate in China is about 2-3%, with a large affected population. Currently, there remains a significant amount of unmet clinical needs for the treatment of autoimmune diseases.

In recent years, small-sample clinical studies abroad have shown encouraging clinical outcomes in treating autoimmune diseases such as systemic lupus erythematosus and anti-synthetase antibody syndrome with autologous CAR-T cells, achieving disease remission without the need for continuous medication.

Currently, there are no autologous CAR-T cell products approved internationally for the treatment of autoimmune diseases. In China, only two autologous CAR-T cell products have been approved for Phase I clinical trials, which are respectively evaluating the safety and efficacy in treating moderate to severe refractory systemic lupus erythematosus and neuromyelitis optica spectrum disorders.

If the new drug registration clinical research application for RJMty19 in treating r/r AID is approved, CD-19 CAR-DNT will be roughly in sync with the clinical development of CAR-T and NK cell products both in China and internationally in the field of autoimmune diseases.

Dr. Yang Liming believes that off-the-shelf通用型CD19-CAR-DNT cell product has significant advantages over autologous CAR-T cell products in terms of price, accessibility, and clinical convenience. Therefore, it holds tremendous clinical value and social significance for treating a large and widespread population of patients with autoimmune diseases.